(117 days)
InQu™ is a resorbable bone void filler intended to fill bony gaps or voids that are not intrinsic to the stability of the bony structure. InQu™ is intended for use as a bone graft substitute in the skeletal system (extremities and pelvis). InQu™ is indicated for use as a bone graft extender in the spine when combined with bone autograft. These defects may be surgically created or result from traumatic injury to the bone.
InQu™ is intended for single patient use only. InQu™ is a sterile, granular, synthetic bone void filler device composed of poly (D, L-lactide-co-glycolide) and hyaluronic acid. It resorbs and is replaced with bone during the healing process.
This document pertains to a 510(k) premarket notification for a medical device called InQu™. As such, it describes the device's intended use, composition, and claims of substantial equivalence to a predicate device. It does not contain information about acceptance criteria or a study demonstrating device performance against such criteria.
The purpose of a 510(k) submission is to demonstrate that a new device is substantially equivalent to a legally marketed predicate device. This typically involves comparing technological characteristics, intended use, and performance data if relevant for safety and effectiveness.
Therefore, I cannot fulfill your request for the following information based on the provided text:
- A table of acceptance criteria and the reported device performance: This information is not present.
- Sample size used for the test set and the data provenance: Not applicable as no specific performance study against acceptance criteria is described.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
- Adjudication method for the test set: Not applicable.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable, as this is a bone void filler and not an AI-assisted diagnostic device.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used: Not applicable.
- The sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
The document indicates that "Testing has confirmed InQu™ is biocompatible, safe and effective as a general bone void filler device and as a bone graft extender in spine." However, it does not provide details of these tests, including acceptance criteria or study methodologies. The core of this 510(k) is the claim of substantial equivalence to its own prior version (K063359), stating it's "in fact the same product as the unmodified predicate device."
§ 888.3045 Resorbable calcium salt bone void filler device.
(a)
Identification. A resorbable calcium salt bone void filler device is a resorbable implant intended to fill bony voids or gaps of the extremities, spine, and pelvis that are caused by trauma or surgery and are not intrinsic to the stability of the bony structure.(b)
Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance: Resorbable Calcium Salt Bone Void Filler Device; Guidance for Industry and FDA.” See § 888.1(e) of this chapter for the availability of this guidance.